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DirectoryBusiness & Technical ServicesOther Service IndustriesBernMetecon Schweiz GmbH
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Metecon Schweiz GmbH

Summary

About the company

The core activity of Metecon is to advise and support manufacturers of medical devices and in vitro diagnostics in creating and updating product files, conducting verification and validation processes, accompanying clinical affairs and regulatory affairs, and optimizing quality management processes. The goal is to facilitate market access and post-market surveillance of medical devices and IVDs, and to ensure regulatory compliance.

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Products & services

Industry:Other Service Industries
✓ Offered4
Regulatory compliance for medical devices
Regulatory compliance for medical devices with strategic consulting, document review and preparation, quality management systems, clinical evaluation, approval strategy, training, and support for market access.
Regulatory compliance for in vitro diagnostics
Regulatory compliance for in vitro diagnostics with document review and preparation, quality management systems, performance evaluation, clinical studies, training, and support for market access.
EU Authorized Representative (EU-REP/EC-REP)
EU Authorized Representative for Swiss manufacturers of medical devices and IVDs with representation under MDR/IVDR, review of conformity documentation, communication with authorities, and registration requirements.
Swiss Authorized Representative (CH-REP)
Swiss Authorized Representative for foreign manufacturers of medical devices and IVDs with review of conformity documentation, vigilance, reporting to Swissmedic, and document retention.

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Location

Thunstrasse 21
3005 Bern

At a glance

Legal form
Limited Liability Company
UID
CHE-163.455.022
Founded
2023 · 3 years
Last commercial register change
July 15, 2024
Employees
11 to 20

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